Drug factory · FDA FEI 3010165390

Monroe Transfilling, LLC

Monroe, Wisconsin, United States

Matched to FDA's records by company name, because this plant's registration on the label has expired.

Problems found, fixed voluntarily at FDA's last inspection, Jun 2, 2015.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

1 drug inspection on record since 2015: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Oxygen	Makes it	Monroe Transfilling, LLC	73151-001

Ended	Result	Program	Problems noted
Jun 2, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	6

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance.
Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of instruments and gauges is not done at suitable intervals in accordance with an established written program.
Test methods ID and data location 21 CFR 211.194(a)(2)
Laboratory records are deficient in that they do not include the location of the data that assures the accuracy and reliability of the test method.
GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
Written Procedures Not Followed 21 CFR 211.80(a)
Written procedures are not followed for the receipt, sampling, testing, and approval of components.
Components withheld from use pending release 21 CFR 211.84(a)
Each lot of components is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.